UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032982
Receipt number R000037609
Scientific Title Analyses of the skin molecules in patients with Parkinson's disease.
Date of disclosure of the study information 2018/06/20
Last modified on 2018/12/26 11:22:36

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Basic information

Public title

Analyses of the skin molecules in patients with Parkinson's disease.

Acronym

Analyses of the skin molecules in patients with Parkinson's disease.

Scientific Title

Analyses of the skin molecules in patients with Parkinson's disease.

Scientific Title:Acronym

Analyses of the skin molecules in patients with Parkinson's disease.

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the skin molecules in patients with Parkinson's disease.

Basic objectives2

Others

Basic objectives -Others

The observational study of the relationship between skin molecules and states of Parkinson's disease.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between skin molecules and states of Parkinson's disease.

Key secondary outcomes

The relationship of the molecules between skin and blood.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Panelists with sporadic Parkinson's disease (Hoehn & Yahr stage I or II).
2.Japanese male panelists who are 20-89 years old.
3.Panelists who agree to have their typical daily routines.

Key exclusion criteria

1.Panelists who use the drug for the treatment of Parkinson's disease
2.Panelists who have the type I or II diabetes.
3.Panelists who have the malignant tumors or history of them.
4.Panelists who have the skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis vulgaris.
5.Panelists who have the infectious diseases, such as HIV, HCV, HIV, and syphilis.
6.Panelists who use the antibiotics within 2 weeks before participation in this study.
7.Panelists who use the prescription drugs having any effects to this study.
8.Panelists who use the prescription topical agents on the face

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayoshi Inoue

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7498

Email

inoue.takayoshi@kao.com


Public contact

Name of contact person

1st name
Middle name
Last name Yuya Uehara

Organization

Kao Corporation

Division name

Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7461

Homepage URL


Email

uehara.yuuya@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo University

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

順天堂大学医学部付属順天堂医院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The observational study of the relationship between skin molecules and states of Parkinson's disease.


Management information

Registered date

2018 Year 06 Month 14 Day

Last modified on

2018 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037609


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name